Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma

Summary

In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. New strategies for treatment need to be identified which enhance local control above the current treatment regimen in order to achieve further clinical gains in this disease. Favorable early experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can identify active tumor beyond standard MRI as well as high risk regions at risk for local failure. There is also clinical evidence that limited field dose escalation with either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe. Coupling these findings provide the rationale for this proposed Phase II trial designed to define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.

Conditions

• Glioblastoma

Interventions

RADIATION

Intensity Modulated Radiation Therapy

IMRT treatment will consist of 60 Gy in 30 fractions to PTV 60

DRUG

Temozolomide

Concurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days: * Concurrent during Radiation Therapy: 75 mg/m\^2 orally for 6 weeks; * Post-radiation, adjuvant therapy: 150 mg/m\^2 - 200 mg/m\^2 orally daily on days 1 - 5 of each cycle.

BEHAVIORAL

Functional Assessment of Cancer Therapy-Brain (FACT-Br)

FACT-Br Quality of Life (QOL) questionnaire to be completed by study patients as protocol specific timepoints

RADIATION

Stereotactic Radiosurgery Boost

Patients will undergo SRS boost in a single fraction dose prior to IMRT treatment: HTV Maximum dimension vs. Prescribed Dose to HTV: ≤ 20 mm = 21 Gy; 21 mm - 30 mm = 18 Gy; 31 mm - 40 mm = 15 Gy.

RADIATION

Simultaneous Integrated Boost

Treatment shall consist of 60 Gy in 30 fractions to planning target volume (PTV) 60 and 75 Gy in 30 fractions to PTV 75.

DEVICE

3D MRSI

Three Dimensional Magnetic Resonance Spectroscopy Imaging (MRSI) during pre-treatment, week 3 during radiation therapy, end of radiation therapy; will include standard gadolinium enhanced MRI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant temozolomide therapy, per protocol.

Sponsors & Collaborators

• University of Miami

  lead OTHER

Principal Investigators

• Fazilat Ishkanian, MD, PhD · University of Miami

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States

Study Locations